Herbal composition and treatment methods

ABSTRACT

An herbal treatment composition is provided which includes Sarcandra glabra and a polysaccharide derived from medicinal mushrooms. Methods for treating psoriasis and purpura using the composition are also disclosed.

BACKGROUND OF THE INVENTION

The invention relates to an herbal composition and treatment method and,more particularly, to a specific herbal composition which is useful intreating disorders such as psoriasis and purpura.

Psoriasis is a chronic and disturbing skin disorder, which is manifestedby various characteristics such as the formation of scaly patches orflat-topped papules that cause itching. The cause of the disorder isunclear, and current treatments include topical fluorinatedcorticosteroids, vitamin A, and vitamin D, which are prescribed only forsuppressive therapy. With approximately 150,000 new cases of psoriasisdiagnosed in the United States each year, the need remains for suitabletreatments.

Purpura is a condition of the skin marked by purple or livid spotscaused by tiny hemorrhages that invade the tissue, occasionallyaccompanied with gum or nose bleeding, increased bleeding time,prolonged menstruation, anemia, blood in stools, low fever, headache andother infection-like symptoms. Purpura may also occur in the mucousmembranes such as the lining of the mouth, and in internal organs. Thereis no known cure for purpura in current western medicine, and ifsymptoms persist, corticosteroids such as Prednisone™ are prescribed.Clearly, the need remains for suitable treatments for purpura as well.

In light of the foregoing, it is the primary object of the presentinvention to provide a composition and method for treating psoriasis.

It is a further object of the present invention to provide a compositionand method for treating purpura.

It is a still further object of the present invention to provide acomposition and treatment method for treating psoriasis, purpura andother disorders wherein treatment is simple and accompanied by little orno side effects.

Other objects and advantages of the present invention appearhereinbelow.

SUMMARY OF THE INVENTION

In accordance with the present invention, the foregoing objects andadvantages have been readily attained.

According to the invention, an herbal treatment composition is providedwhich comprises Sarcandra glabra and a polysaccharide. Thepolysaccharide is preferably a polysaccharide derived from the groupconsisting of Lentinus edodes, Ganoderma lucidum, and mixtures thereof,preferably including both Lentinus edodes and Ganoderma lucidum as wellas Grifola and Cordyceps.

In further accordance with the present invention, a method for treatingpsoriasis is provided, which method comprises the steps of providing anherbal treatment composition comprising an ingredient selected from thegroup consisting of Sarcandra glabra, a polysaccharide and mixturesthereof; and administering said composition to a mammal havingpsoriasis.

In further accordance with the present invention, a method for treatingpurpura is provided, which method comprises the steps of providing anherbal treatment composition comprising an ingredient selected from thegroup consisting of Sarcandra glabra, a polysaccharide and mixturesthereof; and administering said composition to a mammal having purpura.

DETAILED DESCRIPTION

The invention relates to an herbal treatment composition and severaltreatment methods. As will be further set forth below, the herbaltreatment composition may suitably be provided in the form of a liquidherbal concentrate, a dry powder or powdered herbal concentrate,capsules, tablets, topical sprays, cream or ointment and the like, whichincludes one or more ingredients which have been found to be desirablein accordance with the invention.

In accordance with the present invention, it has been found thatsarcandra glabra, particularly when combined with polysaccharides,especially those derived from medicinal mushrooms such as Grifola,Lentinus edodes (Shiitaki), Cordyceps and Ganoderma lucidum (Reishi)provides excellent results in treatment of psoriasis and purpura.

Sarcandra glabra is an herb that grows in Southern China. It has beendocumented that Sarcandra glabra has antiseptic activity and istraditionally used in Chinese medicine for treating inflammation, bloodstasis, arthritis, parasite and cold. The chemical composition ofSarcandra glabra includes coumarin/furocoumarin and derivatives,flavones, lactones, glucosides and glucans such as sesquiterpenelactone,pelargonidin, and 3-rhamnosylglucoside. Sarcandra glabra is non-toxic inhumans at therapeutic dosages of about 25 grams. The safe dose asindicated through studies conducted with mice is 51.2 grams per kilogramof body weight.

The polysaccharide and derivatives which combine advantageously withSarcandra glabra include polysaccharides, oligosaccharides, lectin,glucans, glycans, peptide/protein associated poly or oligosaccharides orglycans/glucans, and derivatives thereof which are collectively referredto herein as polysaccharides. Specific polysaccharides preferablyinclude glucose, arabinose, mannose, xylose, galactone, and the like,and mixtures thereof.

It is further preferred that the composition include some crude extractof one or more of the aforementioned medicinal mushrooms, mostpreferably of Ganoderma and Cordyceps, so as to include in thecomposition additional diverse biologically active compounds includingadditional polyssacharides, glucans, glycans, balanoides, balanol,ophiocordin, ophioglossoides, lectins, lanostane/derivatives,triterpenoids/derivatives, various vitamins, amino acids and minerals.

According to the invention, the herbal treatment composition preferablyincludes the aforesaid polysaccharide or polysaccharide derivatives ineffective amounts, and likewise an effective amount of Sarcandra glabra.Although the composition can be provided having a concentration orcontent of Sarcandra glabra which is tailored specific to the particularpatient and condition being treated, the herbal treatment composition ofthe present invention preferably includes Sarcandra glabra in aconcentration of at least about 10 mg/ml or g, and is administered intreatment amounts of about 1-1.5 ml or g depending upon the form of thecomposition. Composition amounts may therefore be referred to herein asweights per unit composition.

The herbal treatment composition in accordance with the presentinvention, as set forth above, includes polysaccharide or polysaccharidederivative, which may preferably be provided from Grifola and/orLentinus edodes, most preferably from a mixture of both. Thesepolysaccharides and derivatives are a group of chain molecules which canbe extracted from various sources, most preferably from edible mushroomssuch as Cordyceps, Ganoderma lucidum (Reishi), Lentinus edodes(Shiitaki), Grifola, hericium, poria, and the like, and mixturesthereof, most preferably from a combination of Cordyceps, Ganodermalucidum, Lentinus edodes and Grifola. This group of chain moleculesincludes polysaccharides, oligosaccharides, lectins, glucans, glycans,peptide/protein associated poly or oligosaccharides or glycans/glucans,and mixtures thereof. The polysaccharide consists chemically of glucose,arabinose, manose, xylose and galactone.

The composition of the present invention preferably includespolysaccharide or derivatives thereof derived or extracted from Grifolaand Lentinus edodes mushrooms, and most preferably includes a portion ofGrifola, Cordyceps, Lentinus edodes and Ganoderma lucidum mushrooms,each of which may contribute to the total polysaccharide content of thecomposition, and further which mushrooms may themselves be present inthe final composition in the form of crude extract of mushrooms. Crudeextract portions of the mushrooms include those portions which aresoluble in water/ethanol.

In further accordance with the present invention, the herbal treatmentcomposition most preferably includes a concentration of Sarcandra glabraof between about 10 and about 600 mg/ml or mg/g; a concentration ofLentinus edodes of between about 5 and about 200 mg/ml or g, and aconcentration of Ganoderma lucidum of between about 3 and about 450mg/ml or g. The composition preferably includes polysaccharide orderivatives and mushrooms as set forth above, for example as crudeextract, in amounts sufficient to provide polysaccharide in thecomposition of the present invention in concentrations of between about5 and about 1000 mg/ml or g.

The herbal treatment composition of the present invention has been foundto have excellent results in treating psoriasis and purpura, and mayfurther be useful for treating other disorders, diseases and the like.In treating psoriasis and/or purpura, the herbal treatment compositionof the present invention may suitably be administered to a mammalianpatient either orally as a liquid or powder concentrate to be added to aliquid, or in pill, capsule or tablet form, or topically as a spray,cream, ointment or the like. For example, the treatment composition ofthe present invention may be provided in a standardized formulacontaining Sarcandra glabra at a concentration of between about 10 andabout 600 mg/g or ml and polysaccharides in a concentration of betweenabout 5 and about 1000 mg/g or ml, and this standardized formula can beadministered to a patient for example in 1-1.5 gram dosages of formula,several times per day. In accordance with the present invention, it hasbeen found that such a regimen or treatment method advantageouslyprovides for improvement in psoriasis and purpura conditions, andfurther does not appear to have any side effect or undesirable result.

The composition of the present invention preferably contains the desiredingredients as follows:

    ______________________________________                                        Sarcandra glabra                                                                              10-30% wt                                                     Ganoderma lucidum                                                                             15-30% wt                                                     Cordyceps       5-15% wt                                                      Lentinus edodes 5-25% wt                                                      Grifola         5-25% wt                                                      ______________________________________                                    

In addition, the composition of the present invention preferablyincludes between about 5% wt and about 45% wt of the desiredpolysaccharide or polysaccharide derivatives, which are present from oneor more of the mushroom components of the composition of the presentinvention. These values are provided on the basis of the entirecomposition, prior to mixing with liquid or powder carriers or solventsand the like.

It should be noted that the term polysaccharide as used herein isspecifically intended to include polysaccharide derivatives such asthose described above.

The following clinical data shows the excellent results obtained usingthe herbal treatment composition in accordance with the presentinvention to treat humans suffering from psoriasis and purpura.

EXAMPLE 1

This example sets forth a clinical study in connection with the skindisorder classified as psoriasis. A test population of 58 people whowere classified as having psoriasis were included in a study. This groupincluded 43 males and 15 females. The patients ranged in age from 5-79years old, and 76% of the patients were in the range of 16-35 years inage. Of the patients tested, 45 had psoriasis for about 2 years prior tothe study. Others in the group had the disorder for periods of 1 year to25 years. This group of patients was classified as patients havingcommon type psoriasis, and 40 of the test cases were in a first clinicadmission, while others had experienced remittent psoriasis 2-10 timesduring the course of their life time.

The protocol of treatment consisted of administering 1-1.5 grams of drypowder having a composition as follows:

    ______________________________________                                        Sarcandra glabra     28%                                                      Mushrooms and polysaccharide                                                                       72%                                                      Ganoderma            27%                                                      Cordyceps            15%                                                      Lentinus and Grifola 18%                                                      (as crude extract)                                                            Polysaccharide       12%                                                      ______________________________________                                    

The composition was given orally 3 times per day for 3 months. No othertopical or internal treatment was applied during the period of thistesting. At the end of the 3 month period, itching and size of scalypatches and flat-topped papules were measured. The results can beclassified into three groups. In group 1, 38 of the patients showed 99%to 100% restoration of normal skin health, and had no itching complaint,no visible scaly patches or flat-topped papules, or only tiny spots ofsame when subjected to close observation. In group 2, 14 of the casesshowed an improved condition indicated by more than 50% restoration ofnormal skin health, no complaint of itching, and reduction of scalypatches and papules by more than 50% of original size. A third groupcontaining the remaining 6 patients showed a lesser response, showingless than 50% restoration of normal skin health and reduced butcontinuous itching and less than 50% reduction in the size of scalypatches or papules.

No obvious side effects were observed in any of the 58 patients. Nodiscomfort complaints were registered by any patient, and no symptomrebounding was observed during or after the treatment. Further, allliver, blood and urine examinations showed normal signs after thetreatment.

From this clinical study, it can be concluded that the treatmentcomposition of the present invention provided a complete response for65.5% of the patient population, and at least significant improvement ina total of 89.6% (Groups 1 and 2 of the patient population).

Of the 38 cases in group 1, short term post treatment follow ups wereconducted and showed no symptomatic rebound. This suggests that therestoration is not due to remittent effect, but instead is due to thetreatment of the present invention.

EXAMPLE 2

This clinical study demonstrates use of the treatment composition andmethod of the present invention to treat purpura. Twenty six people whowere classified as having purpura were included in this study. These 26patients broke down as 10 acute cases, and 16 chronic cases. The 26people population consisted of thirteen males and thirteen females, andage of the patients ranged from 3 years to 31 years. The majority ofpatients tested had had the disease for about 2 years. Several othershad had the disease from a period of about 2 days to about 10 years.These 26 people were classified as patients having common type purpura,some accompanied with dizziness and fatigue. The platelet counts ofthese patients ranged from 36,000 to 80,000/mm³.

A dry powder of the composition of the present invention having acomposition as set forth in Example 1 was administered to each patientin the study group. The standardized formula was administered threetimes per day, orally, in treatment amounts of 1-1.5 grams, for a periodof 45 days. The acute cases of the test group were treated 4 times perday. Bleeding time and purple or livid spots on the skin were measuredboth during and after the treatment. Platelet count was examined on thetenth day of treatment.

Purple or livid spots on the skin disappeared in all patients of thegroup in 7 to 15 days from the beginning of the treatments. Plateletcounts of all patients had increased by 10, 000/mm³ after 10 days oftreatment. Bleeding time had become normal at the end of the treatment.Further, no obvious side effects were observed and no noticeablediscomfort complaints were registered. All liver, blood and urineexaminations showed normal after the treatment, and no symptomrebounding was observed after the treatment.

This clinical study indicates that the treatment composition of thepresent invention is in fact effective in responding to the skindisorder classified as purpura. Favorable response in the 26 testers was100%, and short term (6 months) post treatment follow up of all testersindicated no symptomatic rebound.

In light of the foregoing Examples 1 and 2, it is concluded that thetreatment composition in accordance with the present invention iseffective for advantageously treating conditions such as psoriasis andpurpura. Furthermore, other advantageous applications for thiscomposition may be developed.

A further description of the Sarcandra glabra ingredient of thecomposition of the present invention can be found in the following: TheEncyclopedia of Traditional Chinese Medicine (Jiagsu New MedicalCollege, Zhongyao Dachidian), Peoples Publishing Company, Shanghai pages42-3 (1986); Li et al. "Diagnostic significance of the CuticularPatterns on Leaf Surface of Sarcandra Glabra", Yao Hsueh Hsueh Pao 1990;25(9): 717-20; Wang et al. "A New Sesquiterpene Lactone from SarcandraGlabra", Yao Hsueh Hsueh Pao January 1988; 23(1): 64-6.

A further description of Grifola mushrooms can be found in severalreferences including: Chang R. "Functional Properties of EdibleMushrooms" [Review ] [22 refs.] Nutr. Rev Nov; 54 (11 Pt 2): S91-3,1996; Miura NN, etc. "Blood Clearance of (1-3)-beta-D-glucan in MRl 1pr/1 pr mice." FEMS Immunol Ded Microbiol, 13(1):51-57, January 1996;Yadoma T. "Enhancement of Cytokine Production by Macrophages Stimulatedwith (1-3)-beta-D-glucan, Grifolan (GRN), isolated from Grifolafrodosa." Biol Pharm Bull; 17 (12):1554-60, 1994.

Further description of Cordyceps mushrooms to be used as an ingredientin accordance with the present invention can be found in the followingreferences: Kuo, YC and Tsai, W. J. "Cordyceps Sinensis as anImmunomodulatory GEN" AM J Chin Med, 24(2): 111-25, 1996; Manabe, N. andSugimoto, M. "Effects of the Mycelial Extract of Cultured CordycepsSinensis on in Vivo Hepatic Energy Metabolism in a Mouse" Jpn JPharmacol 70(1): 85-8, 1996; Yin, D. and Tang, X "Advances in the Studyon artificial cultivation of Cordyceps Sinensis." Chung Kuo Chung YaoTsa Chih 20(12); 707-9, December 1995.

Further description of the Ganoderma ingredient of the composition ofthe present invention can be found in the following references: Van dehem LG, et al. "Ling Zhi-8: Studies of a New Immunomodulating Agent."Transplantation, 15;60(5): 438-43, September 1995; Yamawai, MN. andShimada, A. "A Lectin from Mycelia of the Fungus Ganoderma Lucidum"Phytochemistry 44(1):7-10, January 1997; Cuella, N. J. J. and Giner, R.M. "Two Fungal Lanostane Derivative as Phospholipase A2 Inhibitor." JNat Prod; 59(10):977-9, October 1996.

Further references can be found in connection with the Lentinusingredient of the composition of the present invention in the followingpublications: Tamura, R. and Tanebe, K. "Effects on Lentinan on AbnormalIngestive Behaviors Induced by Tumor Necrosis Factor." Physio Behav61(3):399-410, March 1997; Chang, R. "Functional Properties of EdibleMushrooms" Nutr Rev 54(11 Pt 2):S91-3 November 1996; Jin M. and Kim, S."Induction of B cell Proliferation and NF-kappa B Activation by a WaterSoluble Glycan from Lentinus Lepideus." Int J. Immunopharmacol; 18(8-9): 439-48, August-September 1996.

This invention may be embodied in other forms or carried out in otherways without departing from the spirit or essential characteristicsthereof. The present embodiment is therefore to be considered as in allrespects illustrative and not restrictive, the scope of the inventionbeing indicated by the appended claims, and all changes which comewithin the meaning and range of equivalency are intended to be embracedtherein.

We claim:
 1. A method for treating psoriasis comprising the steps of:1)providing an herbal composition comprising Sarcandra glabra extract andpolysaccharide-containing extracts of Grifola and Lentinus edodes; and2) administering an effective amount of said composition to a subject inneed thereof.
 2. The method according to claim 1, wherein thecomposition farther comprises extracts of Ganoderma lucidum andCordyceps.
 3. The method according to claim 1, wherein the Sarcandraglabra extract comprises coumarin or furocoumarin, flavones, lactones,glucosides and glucans.
 4. The method according to claim 1, wherein saidSarcandra glabra extract is present in a concentration of at least about10 mg per unit composition.
 5. The method according to claim 1, whereinsaid Sarcandra glabra extract is present in a concentration of betweenabout 10 and about 600 mg per unit composition.
 6. The method accordingto claim 1, wherein said polysaccharide is present in a concentration ofat least about 5 mg per unit composition.
 7. The method according toclaim 1, wherein said polysaccharide is present in a concentration ofbetween about 5 and about 1000 mg per unit composition.
 8. A methodaccording to claim 1, wherein said composition is a liquid.
 9. Themethod according to claim 1, wherein said composition is a dry powder.10. A method for treating psoriasis comprising the steps of:1) providingan herbal composition based on the total weight of extracts andpolysaccharides as follows:

    ______________________________________                                        Sarcandra glabra extract                                                                        10 to 30% wt                                                Ganoderma lucidum extract                                                                       15 to 30% wt                                                Cordyceps extract 5 to 15% wt                                                 Lentinus edodes extract                                                                         5 to 25% wt                                                 Grifola extract   5 to 25% wt                                                 ______________________________________                                    

wherein said composition contains between about 5% wt and about 45% wtof said polysaccharides; and 2) administering an effective amount ofsaid composition to a subject in need thereof.
 11. The method accordingto claim 10, wherein the Sarcandra glabra extract comprises coumarin orfurocoumarin, flavones, lactones, glucosides and glucans.
 12. A methodfor treating purpura comprising the steps of:1) providing an herbalcomposition comprising Sarcandra glabra extract andpolysaccharide-containing extracts of Grifola and Lentinus edodes; and2) administering an effective amount of said composition to a subject inneed thereof.
 13. The method according to claim 12, wherein thecomposition further comprises polysaccharide-containing extracts ofGanoderma lucidum and Cordyceps.
 14. The method according to claim 12,wherein the Sarcandra glabra extract comprises coumarin orfurocoumnarin, flavones, lactones, glucosides and glucans.
 15. Themethod according to claim 12, wherein said Sarcandra glabra extract ispresent in a concentration of at least about 10 mg per unit composition.16. The method according to claim 12, wherein said Sarcandra glabra ispresent in a concentration of between about 10 and about 600 mg per unitcomposition.
 17. A method according to claim 12, wherein saidpolysaccharide is present in a concentration of at least about 5 mg perunit composition.
 18. A method according to claim 12, wherein saidpolysaccharide is present in a concentration of between about 5 andabout 1000 mg per unit composition.
 19. The method according to claim12, wherein said composition is a liquid.
 20. The method according toclaim 12, wherein said composition is a dry powder.
 21. A method fortreating purpura comprising the steps of:1) providing an herbalcomposition based on the total weight of extracts and polysaccharides asfollows:

    ______________________________________                                        Sarcandra glabra extract                                                                        10 to 30% wt                                                Ganoderma lucidum extract                                                                       15 to 30% wt                                                Cordyceps extract 5 to 15% wt                                                 Lentinus edodes extract                                                                         5 to 25% wt                                                 Grifola extract   5 to 25% wt                                                 ______________________________________                                    

wherein said composition contains between about 5% wt and about 45% wtof said polysaccharides; and 2) administering an effective amount ofsaid composition to a subject in need thereof.
 22. The method accordingto claim 21, wherein the Sarcandra glabra extract comprises coumarin orfurocoumarin, flavones, lactones, glucosides and glucans.